Cardiac and Cancer Specialists on the Need for FDA Reform

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Cardiac and Cancer Specialists on the Need for FDA Reform

Cardiology and oncology are two medical specialties whose members understand the need for new, life-saving drugs and devices. They know, on a first-hand basis, that such technologies can frequently mean the difference between life and death for many patients.

What do cardiologists and oncologists think of FDA? In the past year, CEI commissioned two polls to examine the views of these specialists. The first, a poll of oncologists, was released in August, 1995. It involved a total of 160 telephone interviews with randomly selected hospital-based oncologists. Its margin of error was +/-5.1% at the 95th percentile confidence level -- that is, similar results would have been obtained in 19 out of 20 cases.

The second poll, of 216 randomly selected cardiologists and cardiac surgeons, is being released today. Its margin of error is +/-4.8 percent at the same high confidence level.

Both polls demonstrate highly negative views of FDA on such issues as whether the agency is too slow in approving new drugs and devices, whether the public understands the human cost of FDA delays, and whether FDA delays impair the ability of these specialists to give the best possible care to patients. Both polls demonstrate overwhelming opposition to FDA's policy of restricting information about off-label use, and strong support for making unapproved therapies available to physicians as long as they are clearly labeled as being unapproved.

There were minor differences on some questions. For example, a majority of cardiologists (57%) believe that FDA approval delays result in patient deaths, while oncologists were just about evenly split on this issue (47% agreeing, 48% disagreeing). But even here, where negative views of FDA were not held by a majority of oncologists, the fact that such a large percentage of them were critical is itself of serious concern. Something is wrong when an agency charged with protecting public health is viewed this negatively by physicians fighting for their patients' lives.

FDA reform is frequently attacked as a pet project of big business that will allegedly open the door to snake oil remedies. This characterization is wrong. As these polls demonstrate, for many medical specialists, fighting heart disease and cancer can often mean fighting FDA. If this isn't a public health problem in need of reform, what is?

Summary of Poll Results

1. On balance, do FDA regulations help or prevent you from using promising new drugs or medical devices in the treatment of your patients? Would that be strongly or just somewhat? Cardiologists Oncologists TOTAL HELP 42% 44% Strongly help 20% 8% Somewhat help 22% 36% TOTAL PREVENT 46% 43% Somewhat prevent 33% 35% Strongly prevent 13% 8% Neither 7% 14% Don't know/Refused 5% -

5. If a drug or medical device has already been approved for one use by the FDA, should the FDA restrict information about off-label uses, that is, other unapproved uses of that drug or device? Cardiologists Oncologists YES 21% 16% NO 67% 76% Sometimes 5% 4% Don't know 5% 1% Refused 2% 3%

6. To what extent does this FDA policy of limiting information make it more difficult for you to learn about new uses for drugs or devices? Cardiologists Oncologists TOTAL MORE DIFFICULT 60% 60% Much more difficult 13% 17% Somewhat more difficult 47% 43% TOTAL LESS DIFFICULT 28% 28% Somewhat less difficult 14% 22% Much less difficult 14% 6% No impact 7% - Don't know 4% 8% Refused 1% 5%

7. Would you say the FDA's approval process has hurt your ability to treat your patients with the best possible care frequently, some of the time, at least once, or never? Cardiologists Oncologists TOTAL HURT ABILITY TO TREAT 71% 63% Frequently 7% 11% Some of the time 45% 37% At least once 19% 15% NEVER 28% 36% Refused 1% 1%

8. What would your position be on a proposal to change FDA law so that unapproved drugs and devices could be made available to physicians as long as they carried a warning about their unapproved status? Would you strongly favor, somewhat favor, somewhat oppose, or strongly oppose such a proposal? Cardiologists Oncologists TOTAL FAVOR 53% 61% Strongly favor 21% 24% Somewhat favor 31% 37% TOTAL OPPOSE 44% 37% Somewhat oppose 24% 24% Strongly oppose 20% 13% Don't know/refused 3% 2%

9. Assume for a moment that a system was in place where unapproved drugs or devices were available to you for treating patients. Which of the following would be the most important factor in your decision to use such an unapproved drug or device? Cardiologists Oncologists Whether persuasive published research exists about the drug or device 47% 59% Whether the drug or device has received approval in other medically advanced countries 25% 29% Whether the drug or device was well-regarded by physician colleagues 19% 10% Don't know/Refused 10% 2%

10. And finally, how many years have you been in practice? Cardiologists Oncologists 5 years or less 7% 14% 5-8 years 7% 14% 8-12 years 14% 14% 12-15 years 17% 11% More than 15 years 56% 47%